External Locking Plate CLP-01Recalls & reported problems
Elevation Spine, Inc. · Saber-C Locking Plate · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810017910069), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT'S ORIGINAL OPERATION OCCURRED ON (B)(6) 2024. IN A POST OP FOLLOW-UP, IMAGING SHOWED WHAT APPEARED TO BE THE LOCKING PLATE DISASSOCIATED FROM ITS INITIAL LOCKED POSITION ON TWO SABER-C SPACERS, AND THE SPIKES APPEARED TO BE MIGRATING OUT OF THE SPACER IMPLANT. A REVISION SURGERY OCCURRED ON (B)(6) 2024 IN WHICH THE IMPLANTED SABER-C LOCKING PLATES AND SPIKE IMPLANTS WERE REMOVED FROM BOTH THE IMPLANTED SPACERS, BUT THE SPACERS THEMSELVES WERE LEFT IMPLANTED. SABER-C SYSTEM BONE SCREWS WERE THEN USED TO FIXATE THE SPACERS IN PLACE AND NEW LOCKING PLATES WERE USED TO COMPLETE THE PROCEDURE.
Patient problems: Inadequate Osseointegration
MAUDE report 20321081 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.